Difference between revisions of "Documentation in EQIPD"
| Line 29: | Line 29: | ||
|[[1.2 Scope|1.2]] | |[[1.2 Scope|1.2]] | ||
|Yes | |Yes | ||
| − | |A brief overview of the | + | |A brief overview of the organisational structure and the communication lines could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] |
|- | |- | ||
|rowspan="3"|'''Quality culture''' | |rowspan="3"|'''Quality culture''' | ||
| Line 36: | Line 36: | ||
|[[1.1 Mission|1.1]] | |[[1.1 Mission|1.1]] | ||
|Yes | |Yes | ||
| − | |The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement] | + | |The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit |
|- | |- | ||
|4 | |4 | ||
| Line 42: | Line 42: | ||
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]] | |[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]] | ||
|No | |No | ||
| − | |These documents usually | + | |These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format |
|- | |- | ||
|5 | |5 | ||
| Line 55: | Line 55: | ||
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]] | |[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]] | ||
|rowspan="3"|Yes | |rowspan="3"|Yes | ||
| − | |Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent | + | |Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent |
|- | |- | ||
|7 | |7 | ||
| Line 71: | Line 71: | ||
|[[2.4 Reporting|2.4]] | |[[2.4 Reporting|2.4]] | ||
|No | |No | ||
| − | |This information could for example be found in presentation as reference to the | + | |This information could for example be found in presentation as reference to the original experiments |
|- | |- | ||
|rowspan="5"|'''Research processes''' | |rowspan="5"|'''Research processes''' | ||
| Line 130: | Line 130: | ||
|No documentation needed | |No documentation needed | ||
|} | |} | ||
| − | |||
| − | Back to the [[EQIPD Quality System]]. | + | |
| + | Back to the [[EQIPD Quality System]] or [[Core Requirements]]. | ||
Revision as of 13:14, 2 December 2020
UNDER CONSTRUCTION
not finalised yet
| Categories | No | Core Requirement | Toolbox reference | Documentation of the Core Requirements | |
| Stand-alone document | Expected documentation | ||||
| Research team | 1 | Process owner must be identified for the Quality System | 1.5.2.3 | No | No documentation needed, verbal agreement sufficient |
| 2 | Communication process must be in place | 1.2 | Yes | A brief overview of the organisational structure and the communication lines could be documented in the Communication plan template | |
| Quality culture | 3 | The research unit must have defined quality objectives | 1.1 | Yes | The Mission statement template could be used to document quality goals of a research unit |
| 4 | All activities must comply with relevant legislation and policies | 1.4.2 | No | These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format | |
| 5 | The research unit must have a procedure to act upon concerns of potential misconduct | 4.2.3 | No | It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available | |
| Data integrity | 6 | Generation, handling and changes to data records must be documented | 2.3.1 | Yes | Could be documented in the Documentation plan and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent |
| 7 | Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs | 3.1.3 | Could be documented in the Documentation plan | ||
| 8 | Reported research outcomes must be traceable to experimental data | 3.1.2.1 | Could be documented in the Documentation plan and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID | ||
| 9 | Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome | 2.4 | No | This information could for example be found in presentation as reference to the original experiments | |
| Research processes | 10 | Investigator must declare in advance whether a study is intended to inform a formal knowledge claim | 2.1.4 | No | This information could be documented in the study/experimental protocol, see 2.1.1 Study (experimental) plan |
| 11 | All personnel involved in research must have adequate training and competence to perform assigned tasks | 3.2.1 | No | Participation in training could be hold available with the training records | |
| 12 | Protocols for experimental methods must be available | 3.5.2 | No | All procedures used in experiments could be hold available in the study/experimental protocol (template) | |
| 13 | Adequate handling and storage of samples and materials must be ensured | 3.3.3 | No | This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol | |
| 14 | Research equipment and tools must be suitable for intended use and ensure data integrity | 3.3.2 | No | Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances | |
| Continuous performance | 15 | Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data | 4.1.1 | No | Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see 2.1.1 Study (experimental) plan and for a risk assessment on the level of the research unit, it could be documented in the Risk assessment template |
| 16 | Critical incidents and errors during study conduct must be analyzed and appropriately managed | 4.2.2 | No | Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate Error reporting document for the research unit level | |
| 17 | An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues | 4.1.2 | Yes | This could be documented in the Self assessment template | |
| Sustainability | 18 | Resources for sustaining the EQIPD Quality System must be available | 1.5.5 | No | No documentation needed |
Back to the EQIPD Quality System or Core Requirements.
